Cleared Traditional

K811302 - SOMATOM 2N

K811302 is the FDA 510(k) clearance for SOMATOM 2N by Siemens Corp.. It is a Class 2 Radiology device (product code IZF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K811302 · Siemens Corp. · Radiology device
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Jun 1981
Decision
43d
Days
Class 2
Risk

K811302 is an FDA 510(k) clearance for the SOMATOM 2N. Classified as System, X-ray, Tomographic (product code IZF), Class II - Special Controls.

Submitted by Siemens Corp. (Mchenry, US). The FDA issued a Cleared decision on June 23, 1981 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1740 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Corp. devices

Submission Details

510(k) Number K811302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date June 23, 1981
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZF System, X-ray, Tomographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZF System, X-ray, Tomographic

All 25
Devices cleared under the same product code (IZF) and FDA review panel - the closest regulatory comparables to K811302.
ORTHORALIX SD/ORTHORALIX SD CEPH
K890351 · Philips Medical Systems North America, Inc. · Jun 1989
ORALIX PANORAMIC D.C.
K852768 · Philips Medical Systems, Inc. · Sep 1985
DIGITILT LS-30 REMOTE CONTROL
K834288 · Elscint, Inc. · Dec 1983
CLINIX-R TOMOGRAPHIC DEVICE
K810274 · Philips Medical Systems (Cleveland), Inc. · Mar 1981
ZONOGRAPH 6
K810307 · Siemens Corp. · Mar 1981
VTX (GE CATAOLG NO. B7005A)
K792067 · General Electric Co. · Dec 1979